BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 9MM

    MDR report key: 12229280 · Received July 27, 2021

    Report

    Report Number
    1038671-2021-00355
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    July 1, 2021
    Report Date
    November 29, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174444
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) AS REPORTED, APPROXIMATELY 2 YRS POSTOP THE INITIAL RTKA, THIS MALE PATIENT HAD A REVISION DUE TO DEEP INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED BY HOSPITAL. UPON REVIEW, THERE IS NO INDICATION OF MANUFACTURING OR DESIGN ISSUES. THE MOST LIKELY CAUSE OF THE REPORTED EVENT APPEARS TO BE THE RESULTS OF THE PATIENT CONDITIONS, WHICH CAUSED THE INFECTION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: THREE PEG PATELLA 41MM (CAT# 200-02-41 / SERIAL# (B)(4)); LOGIC TIBIAL FIT TRAY CEM SZ 4F / 5T (CAT# 02-012-45-4050 / SERIAL# (B)(4)); LOGIC CR FEMORAL POR, RIGHT, SZ 4 (CAT# 02-010-04-0340 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 2 YRS POSTOP THE INITIAL RTKA, THIS MALE PATIENT HAD A REVISION DUE TO DEEP INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126420 LOGIC CR TIB INSERT STD, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM UNK 10885862174444

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention